PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS

K092337 · Baylis Medical Co., Inc. · GXI · Oct 16, 2009 · Neurology

Device Facts

• Record ID: K092337
• Device Name: PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
• Applicant: Baylis Medical Co., Inc.
• Product Code: GXI · Neurology
• Decision Date: Oct 16, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pain Management Optima is intended for use in radiofrequency (RF) heat lesion procedures for relief of pain

Device Story

The Pain Management Optima is a sterile, single-use radiofrequency (RF) probe and cannula system. It is designed to deliver RF energy to create thermal lesions in tissue for pain management. The device is operated by a clinician in a clinical setting. By delivering controlled RF energy, the device creates lesions that interrupt pain signaling pathways, providing therapeutic relief to the patient. The device functions as a delivery tool for RF energy generated by an external RF generator.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Sterile, single-use radiofrequency (RF) lesion probe and cannula. Operates by delivering RF energy to tissue. Class II device (21 CFR 882.4725).

Indications for Use

Indicated for patients requiring radiofrequency (RF) heat lesion procedures for the relief of pain.

Regulatory Classification

Identification

A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.

Predicate Devices

• BMC RF Cannula (K972846)

Submission Summary (Full Text)

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Pain Management Optima

K092337

### 6. 510(k) Summary

#### Submitter Information

A. Company Name: Baylis Medical Company Inc.

B. Company Address: 2645 Matheson Blvd. East Mississauga, Ontario L4W 5S4 Canada

C. Company Phone: [phone]; ext 252

D. Company Facsimile: [phone]

E. Contact Person: Meghal Khakhar

F. Summary Prepared on: 27-July-2009

#### Device Identification

A. Device Trade Name: Pain Management Optima

B. Device Common Name: Radiofrequency Probe

C. Classification Name: Radiofrequency Lesion Probe, 21 CFR 882.4725

D. Device Class: Class II

E. Device Code: GXI

#### Identification of Predicate Device

Predicate device is the BMC RF Cannula, which is cleared under 510(k) Premarket Notification Number K972846

#### Device Description

The Pain Management Optima is a sterile, single-use cannula with an integrated probe used to deliver Radio-Frequency (RF) energy.

#### Intended Use

The Pain Management Optima is intended for use in Radio-Frequency (RF) heat lesion procedures for relief of pain.

#### Special 510(k)

OCT 1 6 2009

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## Substantial Equivalence

,被

The indications for use of the Pain Management Optima are identical to the BMC RF Cannula. Both the Optima and the Cannula are used to create radiofrequency lesions for relief of pain. The fundamental scientific technology of both these devices is also the same.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Baylis Medical Company, Inc. c/o Mr. Meghal Khakhar Regulatory Affairs Manager 2645 Matheson Blyd. East Mississauga, Ontario Canada L4W 5S4

## OCT 1 6 2009

Re: K092337

Trade/Device Name: Pain Management Optima Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI Dated: September 15, 2009 Received: September 24, 2009

Dear Mr. Khakhar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Kesia Alexander Jr

Malvina B. Eydelman, M.D Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

K092337

Device Name: Pain Management Optima

Indications For Use:

The Pain Management Optima is intended for use in radiofrequency (RF) heat lesion procedures for relief of pain

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _1

(Division Signature)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K092337